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PHARMACEUTICAL ENGINEERING MAY/JUNE 2013

regulatory complianceProcess Validation Guidance

Summary

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ife science rms in the US are currentlysubject to two different process validationstandards: the GHTFs Process ValidationGuidance and the FDAs Process Valida-tion: General Principles and Practices .These standards have considerable overlap, both of cially and practically, across the

drug and medical device industries. Previ -ously, all FDA divisions followed a single

guidance document, but that document has long since beensuperseded by new regulations and advances in validationscience. This article examines the differences and similari -ties between the two guidance documents and concludesthat any rm manufacturing product whose predicateregulations require process validation (drugs, devices, activepharmaceutical ingredients, biologics, or human-based tis -sues) should incorporate the philosophies and directives of both to meet Agency expectations and to assure the highestquality of their products. This article does not examine requirements of the na -tional compendia (e.g., the United States Pharmacopeia ), whose validation requirements are much less prescriptivethan FDA guidance documents; and did not include stan -dards from industry groups such as ASTM. Note that whilethis article is speci c to the regulatory requirements of theUS FDA, the GHTF standard examined applies to Europe as well, and the new FDA guidance discussed in this article isunder consideration by the European Medicines Agency asthe possible basis for an E.U. equivalent, 1 currently in com -mittee draft. 2

Introduction Process Validation: General Principles and Practices wasnalized by the US Food and Drug Administrations Centersfor Drug Evaluation and Research (CDER), Biologics Evalu -ation and Research (CBER), and Veterinary Medicine (CVM)in January 2011, nearly two years later than originally pre -dicted by its authors. Notably missing from the new guidances authorship list

is the Center for Devices and Radiological Health (CDRH),one of the main contributors to Guideline on General Principles of Process Validation , the 1987 document which was obsoleted by the 2011 guidance. At rs t glance, thisseems an odd omission, as CDRH was an approver of the1987 standard and has been instrumental in establishingthe state of the art in life science validation practices in the years since.

Background21 CFR 820.75 states where the results of a process can-not be fully veri ed by subsequent inspection and test, the process shall be validated with a high degree of assurance .This fully veri ed criterion is highly subjective on the partof an inspector; while some rms argue that because they100% inspect product they therefore fully verify the outputof their manufacturing process, an FDA inspector need notactually agree with that assertion. Although inspections andtests may be mitigations used to reduce the overall amountof formal validation required, CDRH generally demands validation of the overall manufacturing process. A review ofthe 1996 Preamble to the Quality System Regulation offerssome insight:

A Comparison of Process Validation Standards

by Jeff Boatman

This article presents a comparison between the Global Harmonization Task Force (GHTF) validation standard and the US Food and Drug

Administrations (FDAs) process validation guidance.

eprinted fromHARMACEUTICAL ENGINEERING

OFFICIAL TECHNICAL MAGAZINE OF ISPE

AY/JUNE 2013, VOL 33, NO 3opyright ISPE 2013

ww.PharmaceuticalEngineering.org


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2 MAY/JUNE 2013 PHARMACEUTICAL ENGINEERING


One of the principles on which the quality systems regu -lation is based is that all processes require some degreeof quali cation, veri cation, or validation, and manu - facturers should not rely solely on inspection and testing

to ensure processes are adequate for their intended uses.

Since that time, the medical device industry has been subjectto stringent, science- and statistics-based validation ex -pectations. For example, the concept of ongoing process validationi.e., that Performance Quali cation (PQ) is notthe end of validation, but merely the event that marks thestart of commercial productionis a new concept in the 2011guidance, but a longstanding expectation of medical devicerms under the process trending requirements of 21 CFR820.70 and 820.100. The new FDA document also reliesheavily upon statistical analysis, control, and prediction, while statistical expectations are already built into the Qual -ity System Regulation; and Statistical Process Control (SPC)and process capability tracking and trending (C p/C pK) arethe norm at medical device manufacturers. It might therefore seem mysterious that CDRH would not be a signatory to this seminal validation guidance. Prior tothe nalization of the new guidance, the author discussedthis with contacts within both CDRH and the Center forDrug Evaluation and Research (CDER), who con rmedthat by mutual agreement, CDRH would instead utilize theGlobal Harmonization Task Force (GHTF) process valida -tion standard, SG3/N99-10:2004, Quality Management Systems Process Validation Guidance .3 A clue to this

internal discussion was present in the footnotes of FDAs Inspection of Medical Device Firms , which cited SG3/N99-10, and the January 2011 process validation guidance madeit of cial by explicitly stating that device rms were to followSG3/N99-10. That standard was updated in 2004 to re ectthe new validation requirements of ISO13485:2003, Medical Devices Quality Management Systems , which was itselfupdated to harmonize with the more general ISO9001:2000standard. The FDA provided input into the 2003 ISO 13485standard, so it is tting that CDRH utilizes SG3/N99-10. This article will examine the SG3/N99-10:2004 standardto evaluate how it compares to US medical device regulatoryrequirements, current best practices, and especially the new

Process Validation: General Principles and Practices . Thislatter exercise may be of particular interest to combinationproduct manufacturers and rms that produce or market both drugs and devices, and therefore may be subject to both CDRH and CDER and need to comply with the GHTFstandard as well as the 2011 FDA guidance. This analysis is not intended to be a tutorial on process validation or to analyze any validation document in detail.Except to highlight other FDA rules that further explain arequirement, comments are limited to only those instances where the GHTF validation standard appears to con ict

with or provides different expectations than FDAs process validation guidance and current industry best practices.

Operational Qualication (OQ)

A longstanding de nition of OQ is documented veri cationthat all aspects ofequipment that can affect product qual -ity operate as intended throughout all anticipated ranges. 4 Although OQ is not referenced by name in the FDAs process validation guidance, the new guidance incorporates thatmeaning, along with a somewhat controversial requirementthat such veri cations run at operating ranges for as long as would be necessary during routine production. 5

By comparison, the GHTF standard de nes OQ as es -tablishing by objective evidence process control limits andaction levels which result in product that meets all prede -termined requirements. 6 This appears to contradict other validation documents; typically, challenge of the overall pro -cess to ensure it consistently produces acceptable product isconducted only after quali cations have demonstrated thatindividual pieces of equipment operate properly throughouttheir speci ed ranges. 7 Indeed, equating validation to thesuccessful manufacture of product meeting its speci cationsis a throwback to the original de nition of validation in the1978 drug GMPs; 8 that philosophy was abandoned when theFDA published the 1987 process validation guidance. Thisapparent contradiction suddenly makes sense if one equatesproduct to the output of the process. 21 CFR 820.3(r) de nes product as components, manu -facturing materials, in-process devices, nished devices, and

returned devices; clearly these are the outputs of a rigorouslyde ned process. The FDA guidance similarly de nes product as human and animal drug and biological products, includ -ing active pharmaceutical ingredients. 9 SG3/N99-10 doesnot de ne the term. Even if we use the conventional diction -ary meaning (i.e., product equals the result of a process, butnot necessarily the nal product) this is hard to reconcile withestablishing action limits. Therefore, the GHTF documentappears to use the term OQ differently, and in differentsequence, than common US validation industry usage; but asthis article will explain, this really is not an issue. The FDA process validation guidances, both old and new,expect engineering studies to be performed to determine the

critical processing parameters and their operational rangesthat produce acceptable nal product. Indeed, the 2011guidance devotes an entire section to this practice and hasspeci c expectations regarding its documentation. The GHTF document also describes these activities, butassigns them to the OQ phase instead of an earlier, pre- validation phase. 10 The GHTF OQ is therefore more of anexploratory experiment than a rigorously de ned protocol. Reducing this to the absurd, a Combination Productmanufacturer might have to perform process capabilitystudies, execute an Installation Quali cation, and then


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repeat the process capability study again as part of an OQin order to satisfy all the relevant validation standards. Theauthor concludes that there is no reason for a rm to changeits current practice to match the GHTF standard, provided

that operating and alert parameters are in fact being deter -mined and documented, and equipment is being quali edas capable of meeting its process speci cations at those lim -its. Whichever documentation approach a rm takes, theycan be con dent that they are following an FDA-endorsed best practice. Note that the 2011 FDA guidance includes an expectationthat such process development activities will be properlydocumented, 11 and medical device rms may consider thatexpectation the next time they are gearing up a productionline. Although that guidance is not signed by CDRH, we will demonstrate later in this article why conformance maystill be essential in order for a device manufacturer to meetCDRH and GHTF requirements.

Risk Management Whether a rm produces drugs or devices, and whether per -formed during operational quali cation or as part of pre-val -idation engineering studies, risk management and statisticaltools are now mandatory. For medical devices, this has beena de facto requirement since CDRH formally adopted ISO14971, Application of Risk Management to Medical Devices .The GHTF standard describes the use of Fault Tree Analysis(FTA) and process Failure Mode Effects Analysis (pFMEA)to determine which aspects of the process pose the greatest

risk to product quality;12

the new FDA guidance describesDesign of Experiment (DoE) studies to identify relation -ships between control and component inputs and processoutput characteristics. 13 The FDA recommends a statisticianor person trained in statistical process control develop themethods used in evaluating ongoing production trends; 14 GHTF recommends the use of sound statistics throughoutthe validation process, 15 for medical devices, both of these tieinto the general regulatory requirement to maintain proce -dures for identifying statistical techniques. 16

Experienced validation professionals have seen rsthandhow all of these tools are essential for an ef cient valida -tion. Without DoE and pFMEA to ag the parameters most

critical to product quality and identify those issues mostlikely to affect the process, validation coverage would haveto be exhaustive. The use of product tree risk assessmentsto cross-check similar processes and materials can reducethe number of nished products whose processes must be validated from hundreds to a handful. And without properand documented statistical strategies, con dence in resultscannot be assured to a predetermined degree, violating thepredicate high degree of assurance requirement in 820.75and inviting an inspector to declare the entire validation ef -fort null and void.

Therefore, the risk assessment and statistical require -ments from both documents should be employed, not onlyto ensure compliance, but because in the long run thesepractices produce better products, reduce complaintsand

inevitably save time and money.

Validation of Overall Process As mentioned in the introduction to this article, the ideathat an entire manufacturing process can avoid validation because the nal nished device is 100% inspected is pa -tently false. Confusingly, the owchart included in the GHTFdocument for determining whether validation is required fora given process leans strongly toward product veri cation 17 (Is Process Output Veri able? > Is Veri cation Suf -cient?). Since SG3/N99-10 has been adopted by CDRH, onemight conclude that CDRH is therefore backing away fromits longstanding fully veri ed stance. However, this ow -chart must be read in light of the validation examples thatfollow it. 18 Processes listed that may be subject to veri ca -tion in lieu of validation include manual cutting operations;testing for color; visual inspection of circuit boards; andmanufacturing of wiring harnesses. These are not compre -hensive manufacturing processes, but are individual stepsor sub-processes within the overall product manufacturingsequence; while veri cation may suf ce for these individualsteps, this in no way exempts the overall manufacturingprocess from validation. The GHTF document merely rein -forces existing requirements in 820.75 and the QSR Pre -

amble: while individual production steps may be exemptedfrom validation based on risk (including the mitigation of veri cation), the overall manufacturing process must still be validated. This is fully compatible with ISPE methodologies, in which system boundaries are de ned; and within those boundaries, process components that have direct impact onproduct are subjected to risk assessment and validated on asub-process level as appropriate. 19 The 2011 guidance doesnot explicitly address quali cations at the process-compo -nent level, except when the mitigation involves the use ofprocess analytical technology; 20 but many device rms haveadopted a PQ/PPQ strategy of performing PQ on indi -

vidual processes and then an overall PPQ to make actualnished product. This strategy, originally suggested by thenow-obsolete 1987 guidance, is certainly compliant; but isrequired by neither the FDA nor GHTF and may well be a waste of time and effort under current rules.

Software ImplicationsBoth the GHTF standard and the 2011 FDA process valida -tion guidance document explicitly exempt software valida -tion from its scope, but do mention that software may be anintegral part of a manufacturing process. 21 In many cases,


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software that operates a manufacturing line is a standaloneprocess deserving its own requirements, speci cations, and validation, and the reader should refer to FDAs General Principles of Software Validation .

For instance, building management systems, and off-the-shelf programs that store labeling artwork and print andreconcile labels, have internal software processes that func -tion independently of the equipment being monitored andoperated; as such, they may warrant their own validationactivity. At the opposite extreme, a simple ProgrammableLogic Controller (PLC) that was coded speci cally to operatea heat sealer is arguably an integral part of that equipment.The exclusion of software validation from SG3/N99-10does not itself prevent simple control software from being validated as part of an equipment OQbut the code should be speci ed [21 CFR 820.70(g)] and if not contained in read-only rmware, maintained under change control [21 CFR820.70(b),(i)]. Note that challenges of ladder logic as part ofequipment quali cations, combined with code documenta -tion and change control, also meet CDER requirements forsuch systems at drug rms. 22

Determinations that software is, or is not, integral toequipment design should be described in validation plans orrisk assessment documents, and should include or refer -ence the softwares 21 CFR 11 (electronic records) impact as well. 23 While no speci c regulation requires separate valida -tion efforts as a result of electronic record implications,many companies have a corporate policy regarding Part 11(and for rms also operating under ISO13485 or the Euro -

pean Medicines Agency, E.U. Annex 11) and tie their valida -tions of systems that process electronic records or electronicsignatures back to that policy based on a separate computersystem audit. Including a systems electronic records impactas part of an equipment assessment can assist in demon -strating compliance with the companys policy and highlightsystems requiring special attention.

Number of RunsThe classic required number of production runs to supporta performance quali cation is three batches or lots. Forexample, the QSR preamble states:

While FDA believes that three production runs during process validation (process validation may be initi-ated before or during design transfer) is the acceptedstandard, FDA recognizes that all processes may notbe de ned in terms of lots or batches. The number threeis, however, currently considered to be the acceptablestandard.

Three is the smallest possible number of runs that can iden -tify a trend, but there is scant scienti c basis for arbitrarilypicking three successful runs as a validation efforts accep -

tance criterion. On this issue, CDRH and CDER are now incomplete agreement: the GHTF document states challengesshould be repeated enough times to assure that the resultsare meaningful and consistent, 24 while the FDA guidance

states the number of samples should be adequate to providesuf cient statistical con dence of quality within a batch and between batches. 25 When questioned during an ISPE tele -conference, the CDER representative stated that the numberof runs had to be enough to demonstrate consistency, but atleast three. 26

The author has con rmed with the FDA 27 certain specialinstances where a PQ could be performed with as little asa single con rming run; but these opportunities are mostlikely to appear at contract manufacturers whose newproducts are simply variants of products and processes for which extensive production and validation history alreadyexist. The reader should further bear in mind that a lotis often de ned by the rm in terms of nancial impact orpracticality, which may bear little relationship to validation.For example, declaring a lot to consist of 30 units becausethere are 30 rows to record serial numbers on a DeviceHistory Record or because the electronic batch record has alimit of 1,000 bottles of drug may result in tidy paperwork, but is a poor predictor of likely process variability. Valida -tion plans and protocols should avoid dogmatic de nitionsof batch, lot, and run and rely instead upon risk assess -ments, and where appropriate, Analyses of Variance.

Historical Data

Basing validation and production sampling on historicalparametric data is more ef cient than reliance on attributegeneralizations. Savvy manufacturing engineers know that by maintaining good records during process design activi -ties, data from those studies can be analyzed to provide veryef cient sampling plans and realistic acceptance criteria. Forexample, tight historical s tandard deviations encounteredduring process capability trials might statistically justifytaking only 10 samples per run during PQ, while simply rely -ing on a generic sampling plan such as Acceptance QualityLimits (AQL) 28 might require 50 samples. Likewise, estab -lishing an acceptance criterion of 95% con dence that nomore than 1 out of 1,000 units produced is defective is far

more meaningful than inspect 50, pass on one defect, failon two defectsbut the critical tail calculations required tomake such an assertion demand reliable and representativehistorical parametric data. Unfortunately, it is common industry practice to usegeneric AQL tables (or worse, unfounded guesses) as anacceptable, if inef cient, guideline. While AQL and similarsampling plans will continue for the purpose for which they were originally designed (i.e., sampling of product to test forgo/no-go acceptance attributes), the era of using AQLs as asurrogate for sound statistical analyses may be coming to an


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end. As expressed in both the FDA guidance and the GHTFdocument, there is a growing expectation at regulatoryauthorities that manufacturers demonstrate that they havea clear and in-depth understanding of their processes. One

controversial provision of the FDA guidance is a recommen -dation of continued monitoring and/or sampling at thelevel established during the process quali cation stage untilsuf cient data is available to generate signi cant variabilityestimates. 29 The Parenteral Drug Association protestedthat this is an unwarranted expectation, stating in part alimited number of developmental batches would not be suf -cient to develop a statistically sound rationale for commer -cial product distribution. 30 While CDRH has a longstandingexpectation for rms to show thorough understanding andcontrol over their processes, 31 their sibling Center, undersuch industry pressure, may ultimately relax some of theserequirements. Even so, expect to see pharmaceutical rmscoming under increased CDER and District Of ce scrutinyof their statistical controls, with SPC, C pK, and analyses of variance among the likely candidates. The contra-wise argu -ment is that it is acceptable for drug manufacturers to meeta lower validation standard than medical device rms, and with the 2011 guidance, CDER has made it clear that theystrenuously disagree. The above items make sound statistics during processcapability, design of experiment studies, and good documen -tation of their results critically important. GHTF says vali -dation of a process can be partially based on accumulatedhistorical manufacturing, testing, control, and other data re -

lated to a product or process... historical data is not feasibleif all the appropriate data was not collected, or appropriatedata was not collected in a manner which allows adequateanalysis. 32 This means that for any data to be used in a vali -dation exercise, it has to be properly recorded and stored inaccordance with documented quality record procedures per21 CFR 820.180. This mirrors CDRH constraints on the useof retrospective validation data, which in essence precludethe use of such data if not properly recorded or if the dataand the system itself have not been maintained under rigor -ous change control. 33 As a practical matter, relying solelyupon historical data to retrospectively validate a process isno longer permitted by either FDA division.

Ongoing Validation As previously mentioned, ongoing monitoring of process variability and trending is a long-standing CDRH expecta -tion. Any Six-Sigma Green Belt knows that a low C pKmeans excessive waste, and CDRH inspectors are known tospeci cally check for C pK metrics trending below 1.3. TheGHTF document makes it explicit: trends in the processshould be monitored to ensure the process remains withinthe established parameters. When monitoring data on qual -ity characteristics demonstrates a negative trend, the cause

should be investigated, corrective action may be taken andrevalidation considered. 34

What is really new is CDERs application of this strategyto drug rms as well: data collected should include rele -

vant process trendsinformation collected should verify thatthe critical quality attributes are being controlled through -out the process. 35 While CDRH authority is explicit in 21CFR 820.70 and 820.75, CDER argues that it has impliedauthority under the Annual Product Review clause of 21 CFR211.180(e). 36 If that viewpoint ultimately prevails, it will nolonger be acceptable for a rm to have one level of produc -tion surveillance for medical devices and another, lesserstate of control for drugs. The author has seen device compa -nies tell Agency inspectors that validating a given processto a high degree of con dence is impractical or impossible,only to be informed that their competitor is already doing it.Forewarned is forearmed: the QSR Preamble states duringinspections, FDA will assess whether a manufacturer hasestablished procedures and followed requirements that areappropriate to a given device under the current state-of-the-art manufacturing for that speci c device. Finally, some pharmaceutical companies may attempt torevive a decades-old argument that manufacturing inef -ciencies, such as scrapping batches or culling out productthat fails to meet speci cations, is a nancial business riskthat FDA has no authority over, and therefore they do notneed to validate and/or monitor their processes. Such rmsare advised to read another new FDA guidance explain -ing CDERs expectations of a drug manufacturers quality

systems, which concludes that quality must be built intoproduct and processes through Quality by Design , and notestablished through subsequent inspection and test. 37 Whileguidance documents technically do not establish legally en -forceable responsibilities, 38 this represents CDERs currentthinking, and a drug rm will be hard-pressed to explain why their validations and ongoing monitoring should notmeet the state of the art already employed by their sisterdevice companies. Quality by Design, the concept that onemust establish the expectations for a process in advance andthen objectively prove that resulting products and processesmeets those requirements (and not simply test product untilit passes) is not merely an FDA philosophical expectation; it

is United States federal case law. 39

ConclusionThe good news is that a rm using risk assessment tools toperform and document process development; validatingprocesses based on risk and sound statistical principles; andperforming ongoing process monitoring using tools suchas SPC swimlane charts, C pK tracking, and determinationof root and especially special cause of variation, is alreadymeeting both the GHTF and FDA documents. If your rm is not already doing this, GHTF SG3/N99-10


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has an extensive appendix with an excellent explanation ofthese tools and their application. In particular, a company thatproduces combination products or both drugs and devicesespecially within the same facilityshould consider incorpo -

rating aspects of both SG3/N99-10 and Process Validation:General Principles and Practices as described in this article.

References1. http://www.gmp-compliance.org/elements/ProcessVali -

dation_SurveyResults.pdf.2. http://www.ema.europa.eu/docs/en_GB/document_li -

brary/Scienti c_guideline/2012/04/WC500125399.pdf.3. GHTF documents do not currently appear in the CDRH

Consensus Standards list, but SG3/N99-10 is alreadyreferenced in CDRH inspectional procedures such asFDA Compliance Program 7382.845.

4. ISPE Baseline Pharmaceutical Engineering Guide,Volume 5 Commissioning and Quali cation, 2.4.4,International Society for Pharmaceutical Engineering(ISPE), March 2001, www.ISPE.org.

5. Process Validation: General Principles and Practices, IV.C.1: Food and Drug Administration, January 2011.

6. SG3/N99-10:2004 Quality Management Systems Process Validation Guidance, 2.2: Global Harmoniza -tion Task Force, January 2004.

7. Guideline on General Principles of Process Validation, VIII.1.b: Food and Drug Administration, 1987.

8. Title 21 CFR , 211.110(a).9. Process Validation: General Principles and Practices, I.

10. SG3/N99-10:2004, 5.4.11. Process Validation: General Principles and Practices, IV.B.1.

12. SG3/N99-10:2004, Annex A.13. Process Validation: General Principles and Practices,

IV.B.1.14. Process Validation: General Principles and Practices,

IV.D.15. SG3/N99-10:2004, 5.2.16. Title 21 CFR, 820.250.17. SG3/N99-10:2004, 3.1.18. SG3/N99-10:2004, 3.2.19. ISPE Baseline Pharmaceutical Engineering Guide,

Volume 5 Commissioning and Quali cation, 3.3,International Society for Pharmaceutical Engineering(ISPE), March 2001, www.ISPE.org.

20. Process Validation: General Principles and Practices, IV.B.2.

21. Process Validation: General Principles and Practices, I; SG3/N99-10:2004, 0.

22. Title 21 CFR, 211.68.23. Part 11, Electronic Records; Electronic Signatures

Scope and Application, C.1: Food and Drug Adminis -tration, August 2003.

24. SG3/N99-10:2004, 5.525. Process Validation: General Principles and Practices,

IV.C.3.26. Response given by Grace McNally of CDER, co-author

of the then-draft Process Validation: General Principlesand Practices, while addressing the ISPE/FDA telecon -ference of 13 January 2009.

27. Co-presentation between Jeff Boatman and DavidDoleski, Acting Director, Division of Good Manufactur -ing Practice Assessment, FDA/CDER Of ce of Compli -ance; Regulatory Affairs Professionals Society MidwestConference, Indianapolis, IN, October 26, 2011.

28. ANSI/ASQ Z1.4-2008, Sampling Procedures and Tablesfor Inspections by Attribute: American Society for Qual -ity Control, 2008.

29. Process Validation: General Principles and Practices, IV.D.

30. Federal Dockets Management System Docket FDA-2008-D-0559: Parenteral Drug Association, March2009.

31. Title 21 CFR, 820.70(a) and (a)(2).32. SG3/N99-10:2004, 7.33. Medical Device Quality Systems Manual, 4: Food and

Drug Administration, January 199734. SG3/N99-10:2004, 6.1.35. Process Validation: General Principles and Practices ,

IV.D.36. Process Validation: General Principles and Practices,

IV.D.

37. Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, B and C.3: Foodand Drug Administration, September 2006.

38. Process Validation: General Principles and Practices, I39. United States v. Barr Labs Inc, 812 F., Supp 458.

About the Author Jeff Boatman is a Quality SystemsSubject Matter Expert at QPharma, aregulatory and compliance consultingrm in Morristown, N.J. With 23 years inthe medical device and pharmaceuticalindustries, Boatman has worked in virtu -

ally every aspect of life science engineering, from laboratorysupervisor, manufacturing engineer, R&D, and quality andcompliance management. He is a frequent speaker at indus -try conferences and was selected by PharmaVoice Magazineas one of 2010s 100 most in uential people in the drug in -dustry. Boatman graduated from Air University in 1981 witha degree in Nuclear Physics. He can be contacted by email: [email protected]. QPharma, 22 South St., Morristown, New Jersey, 07960USA.

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